Duns Number:687429456
Catalog Number
-
Brand Name
Biotex
Version/Model Number
BT5013
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180992
Product Code
NBY
Product Code Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Public Device Record Key
4ab52782-71e3-4605-b5d3-372521c8286d
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 64 |